Effect of Repaglinide and Metformin Combination Tablet or Rosiglitazone and Metformin in Fixed Dose Combination on Blood Glucose Control in Patients With Type 2 Diabetes

Condition(s) targeted: Diabetes Mellitus, Type 2

Intervention: repaglinide and metformin combination tablet (Drug); rosiglitazone and metformin combination tablet (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Novo Nordisk

Official(s) and/or principal investigator(s):
Campbell Howard, MD, Study Director, Affiliation: Novo Nordisk

This trial is conducted in the United States of America (USA). This trial compares the changes in HbA1c after 26 weeks of repaglinide and metformin fixed dose combination tablet given as twice daily versus three times daily regimens or versus twice daily rosiglitazone and metformin fixed dose combination tablet in subjects with type 2 diabetes currently on monotherapy.

Official title: Effect of Twice Daily Versus Thrice Daily Repaglinide and Metformin Combination Tablet and Rosiglitazone and Metformin in Fixed Dose Combination on HbA1c in Subjects With Type 2 Diabetes

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: HbA1c

Secondary outcome:

Change in 8-point Glucose Profiles

Change in Lipid Profile

Events of hypoglycemia

Safety parameters

Change in Fasting Plasma Glucose

Waist/hip ratio change

Change in body weight

Percentage of subjects achieving sudden levels of HbA1c

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Type 2 diabetes for at least 3 months

- HbA1c between 7. 5-11. 0% on monotherapy or

- HbA1c between 7. 0-10. 0% on dual therapy

- BMI maximum 45 kg/m2

Exclusion Criteria:

- Any clinically significant disease history in the opinion of the investigator

- Severe heart disease

- Pregnancy

Novo Nordisk Clinical Trial Call Center, San Juan 00921, Puerto Rico

Novo Nordisk Clinical Trial Call Center, Glendale, Arizona 85306, United States

Novo Nordisk Clinical Trial Call Center, Mesa, Arizona 85206, United States

Novo Nordisk Clinical Trial Call Center, La Jolla, California 92128, United States

Novo Nordisk Clinical Trial Call Center, San Mateo, California 94401, United States

Novo Nordisk Clinical Trial Call Center, Sacramento, California 95825, United States

Novo Nordisk Clinical Trial Call Center, San Diego, California 92121, United States

Novo Nordisk Clinical Trial Call Center, Chula Vista, California 91911, United States

Novo Nordisk Clinical Trial Call Center, Los Angeles, California 90057, United States

Novo Nordisk Clinical Trial Call Center, Spring Valley, California 91978, United States

Novo Nordisk Clinical Trial Call Center, Redlands, California 92374, United States

Novo Nordisk Clinical Trial Call Center, Colorado Springs, Colorado 80904, United States

Novo Nordisk Clinical Trial Call Center, Hamden, Connecticut 06443, United States

Novo Nordisk Clinical Trial Call Center, Stamford, Connecticut 06905, United States

Novo Nordisk Clinical Trial Call Center, Washington, District of Columbia 20003, United States

Novo Nordisk Clinical Trial Call Center, Ocala, Florida 34471, United States

Novo Nordisk Clinical Trial Call Center, Orlando, Florida 32804, United States

Novo Nordisk Clinical Trial Call Center, Inverness, Florida 34452, United States

Novo Nordisk Clinical Trial Call Center, Plantation, Florida 33324, United States

Novo Nordisk Clinical Trial Call Center, Jacksonville, Florida 32116, United States

Novo Nordisk Clinical Trial Call Center, Jacksonville, Florida 32259, United States

Novo Nordisk Clinical Trial Call Center, Tampa, Florida 33603, United States

Novo Nordisk Clinical Trial Call Center, Clearwater, Florida 33765, United States

Novo Nordisk Clinical Trial Call Center, Longwood, Florida 32779, United States

Novo Nordisk Clinical Trial Call Center, Aventura, Florida 33180, United States

Novo Nordisk Clinical Trial Call Center, Jacksonville, Florida 32205, United States

Novo Nordisk Clinical Trial Call Center, Marietta, Georgia 30066, United States

Novo Nordisk Clinical Trial Call Center, Columbus, Georgia 31904, United States

Novo Nordisk Clinical Trial Call Center, Atlanta, Georgia 30309, United States

Novo Nordisk Clinical Trial Call Center, Nampa, Idaho 83687, United States

Novo Nordisk Clinical Trial Call Center, Aurora, Illinois 60504, United States

Novo Nordisk Clinical Trial Call Center, Arlington Heights, Illinois 60004, United States

Novo Nordisk Clinical Trial Call Center, Chicago, Illinois 60611, United States

Novo Nordisk Clinical Trial Call Center, Chicago, Illinois 60616, United States

Novo Nordisk Clinical Trial Call Center, Vernon Hills, Illinois 60061, United States

Novo Nordisk Clinical Trial Call Center, Oak Brook, Illinois 60523, United States

Novo Nordisk Clinical Trial Call Center, Flossmoor, Illinois 60422, United States

Novo Nordisk Clinical Trial Call Center, Chicago, Illinois 60607, United States

Novo Nordisk Clinical Trial Call Center, Springfield, Illinois 62704, United States

Novo Nordisk Clinical Trial Call Center, Naperville, Illinois 60564, United States

Novo Nordisk Clinical Trial Call Center, Indianapolis, Indiana 46250, United States

Novo Nordisk Clinical Trial Call Center, Des Moines, Iowa 50314, United States

Novo Nordisk Clinical Trial Call Center, Mission, Kansas 66202, United States

Novo Nordisk Clinical Trial Call Center, Topeka, Kansas 66606, United States

Novo Nordisk Clinical Trial Call Center, Erlanger, Kentucky 41018, United States

Novo Nordisk Clinical Trial Call Center, Louisville, Kentucky 40213, United States

Novo Nordisk Clinical Trial Call Center, Baltimore, Maryland 21209, United States

Novo Nordisk Clinical Trial Call Center, Oak Park, Michigan 48237, United States

Novo Nordisk Clinical Trial Call Center, Ann Arbor, Michigan 48186, United States

Novo Nordisk Clinical Trial Call Center, Troy, Michigan 48098, United States

Novo Nordisk Clinical Trial Call Center, Kansas City, Missouri 64111, United States

Novo Nordisk Clinical Trial Call Center, Omaha, Nebraska 68131, United States

Novo Nordisk Clinical Trial Call Center, Las Vegas, Nevada 89123, United States

Novo Nordisk Clinical Trial Call Center, Las Vegas, Nevada 89102, United States

Novo Nordisk Clinical Trial Call Center, Warren, New Jersey 07059, United States

Novo Nordisk Clinical Trial Call Center, Berlin, New Jersey 08009, United States

Novo Nordisk Clinical Trial Call Center, Jersey City, New Jersey 07306, United States

Novo Nordisk Clinical Trial Call Center, Rochester, New York 14609, United States

Novo Nordisk Clinical Trial Call Center, West Seneca, New York 14224, United States

Novo Nordisk Clinical Trial Call Center, Greenville, North Carolina 27834, United States

Novo Nordisk Clinical Trial Call Center, Winston-Salem, North Carolina 27103, United States

Novo Nordisk Clinical Trial Call Center, Asheville, North Carolina 28801, United States

Novo Nordisk Clinical Trial Call Center, Salisbury, North Carolina 28144, United States

Novo Nordisk Clinical Trial Call Center, Cincinnati, Ohio 45245, United States

Novo Nordisk Clinical Trial Call Center, Franklin, Ohio 45005, United States

Novo Nordisk Clinical Trial Call Center, Tulsa, Oklahoma 74136, United States

Novo Nordisk Clinical Trial Call Center, Portland, Oregon 97232, United States

Novo Nordisk Clinical Trial Call Center, Norristown, Pennsylvania 19401, United States

Novo Nordisk Clinical Trial Call Center, Philadelphia, Pennsylvania 19152, United States

Novo Nordisk Clinical Trial Call Center, Springfield, Pennsylvania 19064, United States

Novo Nordisk Clinical Trial Call Center, East Providence, Rhode Island 02914, United States

Novo Nordisk Clinical Trial Call Center, Cranston, Rhode Island 02920, United States

Novo Nordisk Clinical Trial Call Center, Greer, South Carolina 29651, United States

Novo Nordisk Clinical Trial Call Center, Mt. Pleasant, South Carolina 29464, United States

Novo Nordisk Clinical Trial Call Center, Simpsonville, South Carolina 29681-1538, United States

Novo Nordisk Clinical Trial Call Center, Kingsport, Tennessee 37660, United States

Novo Nordisk Clinical Trial Call Center, Knoxville, Tennessee 37920, United States

Novo Nordisk Clinical Trial Call Center, Houston, Texas 77024, United States

Novo Nordisk Clinical Trial Call Center, Plano, Texas 75093, United States

Novo Nordisk Clinical Trial Call Center, San Antonio, Texas 78229, United States

Novo Nordisk Clinical Trial Call Center, Midland, Texas 79705, United States

Novo Nordisk Clinical Trial Call Center, Dallas, Texas 75224, United States

Novo Nordisk Clinical Trial Call Center, Corpus Christi, Texas 78412, United States

Novo Nordisk Clinical Trial Call Center, Houston, Texas 77030, United States

Novo Nordisk Clinical Trial Call Center, Dallas, Texas 75390-8858, United States

Novo Nordisk Clinical Trial Call Center, Virginia Beach, Virginia 23451, United States

Novo Nordisk Clinical Trial Call Center, Lebanon, Virginia 24266, United States

Novo Nordisk Clinical Trial Call Center, Richmond, Virginia 23229, United States

Novo Nordisk Clinical Trial Call Center, Richmond, Virginia 23226, United States

Novo Nordisk Clinical Trial Call Center, Milwaukee, Wisconsin 53209, United States

Clinical Trials at Novo Nordisk

Starting date: November 2006
Last updated: December 11, 2007